Clinical Trials to Validate the Use of Additioned Endoscopy in Endoscopic Retrograde Cholangiopancreatography

November 20, 2017 updated by: Xiangyu Kong, Changhai Hospital

Validation of Clinical Use of Additioned Endoscopy in Endoscopic Retrograde Cholangiopancreatography

Validation of clinical use of additioned endoscopy in Endoscopic Retrograde Cholangiopancreatography(ERCP) treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Investigators recently developed a device named additioned Endoscopy. The purpose of current clinical trial is to evaluate the use of additioned endoscopy in ERCP treatment, specifically in shortening the duration of ERCP operation and lowering incidence of complications.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital, Second Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • People who are indicated to ERCP treatment.

Exclusion Criteria:

  • People who are not suitable for ERCP treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ERCP with additioned endoscopy
This arm will include participants undergoing ERCP with assistance of additioned endoscopy.
Device: Additioned Endoscopy
To evaluate the use of additioned endoscopy in ERCP treatment.
No Intervention: ERCP without additioned endoscopy
This arm will include participants undergoing ERCP without assistance of additioned endoscopy as negative controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of ERCP treatment
Time Frame: Duration of operation in each patient, ie. from beginning to the end of ERCP operation in each patient
To test if additioned endoscopy will have impact on duration of ERCP treatment
Duration of operation in each patient, ie. from beginning to the end of ERCP operation in each patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications of ERCP treatment
Time Frame: up to 1 month after ERCP completion
To test if additioned endoscopy will have impact on incidence of ERCP complications, including perforation, bleeding, post-ERCP pancreatitis.
up to 1 month after ERCP completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Study Chair: Zhaoshen Li, MD, Changhai hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

November 10, 2017

First Submitted That Met QC Criteria

November 20, 2017

First Posted (Actual)

November 22, 2017

Study Record Updates

Last Update Posted (Actual)

November 22, 2017

Last Update Submitted That Met QC Criteria

November 20, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • Additioned Endocopy in ERCP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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